ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32712 results sorted by trial registration date.
  • A self-management intervention for promoting exercise and healing rates for adults with venous leg ulcers.

    The aim of this study is to determine whether a self-management telephone based intervention will promote healing rates, physical activity levels, functional ability and self-efficacy for exercise for adults experiencing venous leg ulceration

  • Dental therapist treatment of early childhood dental decay among preschool children

    The aim of the study is to compare the effectiveness of school dental therapist treatment of early childhood caries against the standard care within Dental Health Services of dentist provided treatment of early childhood caries among children 4 years of age or younger.

  • A randomised phase 2 study of carboplatin with oral vinorelbine followed by maintenance therapy with oral vinorelbine or erlotinib in elderly patients with metastatic non-small cell lung cancer.

    This study will evaluate the safety and efficacy of induction chemotherapy followed by maintenance with one of the two different drugs in elderly patients with metastatic non-small cell lung cancer. Who is it for? you may be eligible to join this study if you are male or female above 70 years and you have been diagnosed with metastatic non-small cell lung cancer. Trial details All participants will undergo upto 4 x 3 weeks cycles of induction chemotherapy with the drugs vinorelbine (taken as an oral tablet) and carboplatin administered into the vein (intravenously). Participants whose disease has not progressed will then be randomly (by chance) allocated to one of two groups. One group will take a vinorelbine capsule on day 1 and 8 of 3 week cycle. Participants in the other group will take one Erlotinib tablet every day. Participants in both groups will take the treatment till progression of disease, unacceptable side effects or if patient chooses not to continue the treatment. Participants will be assessed every 3-6 weeks until disease progression, death or unacceptable toxicities in order to determine quality of life and response to treatment.

  • Does treatment initiated by a Continence Nurse help to improve bladder and bowel problems in people with Multiple Sclerosis?

    Bladder dysfunction in people with Multiple Sclerosis is very common, very distressing and can affect the individual’s quality of life in many ways. Although it is strongly recommended that routine, targeted continence assessment be undertaken, this is poorly done by health professionals and inadequately discussed by patients. By appropriate screening and targeted continence treatment, initiated by a Continence Nurse, it is hoped that symptoms and quality of life will improve. This will be undertaken by comparing two groups of patients with identifiable continence problems, using a simple one page, double sided continence-screening tool, administered by the Continence Nurse. Participants in Group 1 will be offered assessment and management in line with standard continence practice by the Continence Nurse. Follow up will occur at 1, 3(by phone), 6 and 12 months. Participants in Group 2 will be offered standard care by the patient’s Health Care Team and tailored information endorsed by the Continence Foundation of Australia. The patients in Group 2 will subsequently be reviewed by the Continence Nurse following 6 months, and offered treatment as per the patients in Group 1, if symptoms persist.

  • Decreasing screen-based entertainment in young children: The Family@play study

    Time spent in screen-based entertainment has been shown to be associated with adverse health and cognitive outcomes even in young children. Recent evidence suggests that a large proportion of young children exceed recommendations for screen-based entertainment. This project therefore aims to examine the feasibility, acceptability and potential efficacy of a program to reduce screen-based entertainment in young children. The intervention will be delivered to parents in intact groups over a 10-week period. Both the intervention and control groups will participate in the program and therefore we hypothesise that all participants will see improvements in the targeted outcomes. These include but are not limited to decreased screen-based entertainment, easier application of rules to support healthy behaviours and increased parental self-efficacy. Children may also display increases in physical activity and decreased sitting time. Participants’ results concerning their height and weight and time in screen-based entertainment will be forwarded to parents upon completion of analysis.

  • Carbetocin vs Oxytocin at Emergency Caesarean Section

    Reducing maternal mortality rates has been a worldwide goal for many years. Post partum haemorrhage is the main cause of obstetric haemorrhage accounting for 14 million cases worldwide. It is the leading cause of maternal death throughout the world. In Victoria, Australia, in 2002 the post partum haemorrhage rate was 9.2%. Post partum haemorrhage is associated with ICU admission, the need for blood transfusion and a longer hospital stay, which is at considerable cost. The majority of post partum haemorrhage is caused by uterine atony, so finding an effective agent to prevent uterine atony is paramount in reducing maternal morbidity and mortality. Operative delivery is a known risk factor for PPH therefore improving uterine tone at caesarean section is an important parameter if rates are to be reduced. Carbetocin is a synthetic long-acting analogue of oxytocin used to improve uterine tone. Studies have shown that a single intra-muscular injection of carbetocin is more effective than syntocinon infusion for preventing uterine atony at elective caesarean section, and this is the current practice at Frankston Hospital. Carbetocin is currently licensed in Australia to reduce uterine atony at elective caesarean section, however the efficacy at emergency caesarean section is unclear. In this prospective randomised trial we aim to discover if carbetocin 100 micrograms iv or Syntocinon 5 unit iv bolus, is more effective at improving post partum haemorrhage rates in emergency caesarean sections, by measures of need for further uterotonics, need for >5 minutes uterine massage and haemoglobin drop.

  • Orthoses or Flip-Flops for Pain in the Heel: a randomised clinical trial

    There are a number of studies that show that wearing an orthosis within a shoe helps resolution of heel pain. These orthoses often are prescribed to control excessive pronation, which is thought to be a mechanical factor contributing to overload and eventual pain of the tissues in the plantar heel region (also known as the planta fascia). Recently flip-flops have been designed with features similar to that of the orthoses, but without the need to be fitted within a shoe. A potential benefit of a flip-flop is that the high pain levels felt on first step in in the morning might be prevented if a flip-flop in the shape of an orthosis is worn. Wearing the flip-flop continually then might help relieve tissue stress of the plantar fascia and aid resolution of the problem. Interestingly, the material that flip-flops are made of might also be responsible for any pain relieving effect, hence the inclusion of a flat flip-flop as a comparator in this study. The aim of this study is to test if there are any differences between an in-shoe foot orthosis, a shaped flip-flop and a flat flip-flop over 12 weeks wear.

  • Autism early intervention outcomes study

    Autism Spectrum Disorders (ASDs) are defined in terms of social and communicative impairment co-occurring with repetitive behaviours and restricted interests. The most severely affected individuals fail to develop functional language and show little ability or desire for social interaction. The causes of Autism are not known, although the high concordance rate found in twin studies suggests a strong genetic component. Studies of head circumference and imaging studies of brain morphometry have found evidence of increased brain growth beginning within the first year of life, while functional brain imaging in older children and adults has shown abnormal patterns of interactions between brain regions, possibly related to aberrant connections being laid down during earlier stages of development. One model relating these early abnormalities in brain development to the characteristic socio-communicative impairments has hypothesised that early low-level deficits in recognition and orientation towards social stimuli leads to lack of social engagement with primary caregivers during infancy, resulting in decreased exposure to the reciprocal social interactions critical for healthy development of brain circuits responsible for normal social behaviour (Dawson 2008). This model implies that intervention should occur as early as possible to normalize the developmental trajectory and avoid downstream effects, and that a key component of intervention may be to compensate for early deficits in social attention by providing interventions with emphasis on social interaction. Early intervention may also be important in order to take advantage of the increased plasticity present in the first few years of life (Dawson 2008). One such early intervention program consistent with these aims is the Early Start Denver Model (ESDM), a comprehensive early behavioural intervention for infants to preschool-aged children with Autism that integrates applied behaviour analysis with developmental and relationship-based approaches (Rogers et al 2009). A recent randomised control trial in the United States demonstrated significant improvements in clinical outcomes for children receiving ESDM (Dawson et al 2010). After the first 12 months, 18- to 30-month-olds with Autism who received the program showed significant gains in visual processing and improvements in language abilities with subsequent gains in IQ and adaptive behaviour as well as being more likely to receive a less severe diagnosis upon re-assessment. This study seeks to replicate and extend upon the recent positive international findings regarding the benefits of the ESDM model to children with ASD in an Australian context. References: Dawson, G. (2008). Early behavioural intervention, brain plasticity, and the prevention of autism spectrum disorder. Development and Psychopathology, 20, 775-803. Dawson, G., Rogers, S., Munson, J., Smith, M., Winter, J., Greenson, J., Donaldson, A., & Varley, J. (2010). Randomized, Controlled Trial of an Intervention for Toddlers with Autism: The Early Start Denver Model. Pediatrics, 125(1), e17-e23. Rogers, S.J., Dawson, G., Smith, C.M., Winter, J.M. & Donaldson, A.L. (2009). Early Start Denver Model Intervention for Young Children with Autism Manual. Seattle: University of Washington.

  • Web-based Personal Health Management System to Promote Sexually Transmissible Infections (STI) screening

    The aim of this project is to assess the effectiveness of a web-based personal health management system, called healthy.me, to support healthcare management. healthy.me provides consumers condition specific information, as well as online tools to manage their care including a personal health record. We hypothesise that use of healthy.me will improve the uptake of preventative screening activities and this randomized controlled trial will specifically test whether system use is associated with an increased rate of STI screening among young people aged 18-29 years.

  • Reflux in obstructive sleep apnea

    This research will define the mechanisms underlying the presence of gastroesophageal reflux (GOR) in individuals with obstructive sleep apnoea (OSA). Both are common conditions with OSA affecting 1 in 20 individuals and GOR affecting approximately 1 in 12 individuals in the community. Continuous positive airways pressure (CPAP), the most common and effective treatment for OSA has also been found to treat GOR. GOR symptoms are more common in OSA than the general population (14% vs 5%) and increase with increasing OSA severity. Nighttime GOR is a particular worry in individuals with OSA with 1 in 3 OSA patients reporting overnight symptoms. GOR has significant negative health effects in individuals with OSA including painful symptoms and an increase in cancer risk. Identification of the reasons for the increased incidence of reflux in OSA may assist in improving prevention and/or treatment of GOR in individuals with OSA as well as increasing quality of life in these patients. Aims The overall aim of the proposed research is to determine the underlying reason for the presence of gastroesophageal reflux (GOR) in individuals with obstructive sleep apnoea (OSA), including the roles of obesity and arousal from sleep. Furthermore, we aim to determine the effect of OSA treatment with CPAP therapy on nighttime GOR in individuals with and without OSA. . Methods We aim to recruit a total of 80 individuals of mixed gender between the ages of 18 and 70 years of age. Each participant will undergo a 24 hour pH-impedance study for assessment of reflux severity, an overnight sleep study and a DXA scan to assess obesity and fat distribution; or a 48hour recording of oesophageal pH with two consecutive overnight sleep studies, of with CPAP therapy and one without, in a randomised fashion.

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